Dapagliflozin FDA Review For Type 2 Diabetes Treatment

Dapagliflozin CAS# 461432-26-8Dapagliflozin, CAS number 461432-26-8, is currently being reviewed by the FDA for treatment of type 2 diabetes in adults. Developed by Bristol-Myers Squibb and AstraZeneca, the method of action of dapagliflozin is to inhibit the subtype 2 of the sodium-glucose transport proteins, or SGLT2. This particular subtype is responsible for at least 90% of the glucose reabsorption in the kidney. By blocking this  transporter blood glucose is able to be easily eliminated through the urine. As of January 19, 2012  AstraZeneca announced that the Dapagliflozin FDA review has brought forth a complete response letter regarding the New Drug Application (NDA) for the investigational compound dapagliflozin. Both Bristol-Myers Squibb and AstraZeneca stated that they will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application. LGM Pharma is a provider of the API dapagliflozin for research and development.

Foot on ScaleDapagliflozin is being investigated and evaluated for use as a monotherapy, in combination with other anti-diabetic agents, and as an adjunct treatment to diet and exercise in patients with type 2 diabetes. More than 5,000 patients in 19 clinical studies have participated in trials, and the need for newer treatments for the ever growing population of adults with type 2 diabetes is essential. Aston University researchers conducted a study with roughly 450 adults with type 2 diabetes. Each patient was given either one of three dosages of dapagliflozin or a placebo. These patients were all taking the highest maximum dose of metformin, yet still not seeing lowered blood sugar levels. Patients in this study received 24 weeks of treatment with dapagliflozin, and the results were encouraging, showing a significant reduction in blood sugar levels in all patients who were on a dose of dapagliflozin. These results can be further explored here: http://www.youtube.com/watch?v=KTRs0XIsXvQ&feat.

Concerns remain from the FDA, however, as to safety and efficacy of dapagliflozin. Discernment about which patients would benefit the most from the use of dapagliflozin, as well as concerns over cancer risks led to the current request for further data from Bristol-Myers Squibb and AstraZeneca. Clinical trials reported thus far indicate an increased risk for both breast and bladder cancer. About 0.4 percent of women taking dapagliflozin got breast cancer, compared with 0.1 percent of the women in the control group. As for the men in the study 0.3 percent of men who received dapagliflozin got bladder cancer, compared with about 0.05 percent of men who received the placebo. While these numbers are not staggering, some members of the advisory committee of the FDA expressed concern over any risks from dapagliflozin, even in small numbers.

A decision and potential approval of this once a day pill is anticipated by October of 2012.

*UPDATE: Click here to read about the January 2014 FDA Approval of Dapagliflozin.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share: